Sr Engineer, Quality Engineering (Transfers)

Job Description

Support the transfer and manufacture of medical devices across multiple global sites. Collaborate with cross-functional professionals including, but not limited to, R&D, New Product Introduction (NPI), Design Quality Engineering (DQE), Product Quality Engineering (PQE), and Manufacturing to participate in and sustain the transfers of quality and manufacturing processes from New Product Development (NPD) and site-to-site for new and established medical devices. Job duties :

• Collaborate with cross functional engineers and professionals on developing, transferring, and sustaining robust quality and manufacturing processes, implement changes, including process improvements, and supporting projects across multiple global manufacturing sites.
• Participate as a key team member of projects in improving effectiveness and efficiency of established product lines.
• Participate and / or lead efforts to resolve product quality issues.
• Support and / or lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), equipment calibration, internal auditing, and quality metrics data analysis.
• Provide technical skill in many areas of quality engineering such as nonconformances, evaluating inspection data, evaluating process changes, implementing risk analysis, performing test method validations, and analyzing data.
• Work with Supplier Quality Manager / Engineers and suppliers as necessary.
• Support process and test method validation by developing, executing, or reviewing test protocols and reports.
• Coordinate implementation of new equipment and maintenance of existing equipment by reviewing equipment specifications and related qualification (IQ / OQ) reports and unscheduled maintenance reports.
• Support internal and external audits by participating in preparation activities and addressing audits findings.
• Work with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planners to support the transfers and implementation of new products into production or site-to-site.
• Work with R&D and Manufacturing Engineers to develop, review, and update risk analysis documents including product risk assessments and FMEA documents such as pFMEA.
• Provide technical direction to associates as needed to deliver on projects and assigned tasks.
• Meet goals with minimal supervision, lead projects, and manage multiple concurrent projects.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform other duties and responsibilities as assigned.

Qualifications

Desired Qualifications